EXHIBIT 99.1
IMPORTANT FACTORS
HISTORY OF LOSSES; ANTICIPATED FUTURE LOSSES
The Company has experienced continued and significant operating losses since its
inception in 1984 and has an accumulated deficit. The Company anticipates
continuing operating losses for the foreseeable future. The Company's ability to
generate revenues from operations and achieve profitability depends upon a
number of factors, including its ability to successfully complete development
work on and commercialize the Basis(TM) Cardiac Output Monitoring System and the
costs and related timing of implementation of its marketing, sales and
manufacturing activities. There can be no assurance that the Company will be
able to successfully introduce the Basis Cardiac Output Monitoring System or
that the Company will generate revenues or achieve profitability at any time in
the future.
DEPENDENCE ON AND NEED FOR FURTHER DEVELOPMENT OF THE BASIS CARDIAC OUTPUT
MONITORING SYSTEM
The Company's success depends upon the Basis Cardiac Output Monitoring System,
which currently is its sole product. Although product prototypes were found to
perform consistently with the Company's expectations in Company lab and mammal
tests, early results from the Company's product evaluations of the Basis Cardiac
Output Monitoring System and RealFlow Probe indicated the need for modifications
in order to meet the Company's product performance expectations. While the
Company intends to make these modifications before continuing with further
product evaluations at its clinical sites, there can be no assurance that the
necessary modifications can be timely and successfully developed. Any inability
to timely and successfully make the necessary product modifications could delay
or prevent successful commercialization of the Basis Cardiac Output Monitoring
System, which would have a material, adverse effect on the Company's business,
financial condition and results of operations.
FAILURE OF PRIOR CARDIAC OUTPUT MONITORING SYSTEM
In the Company's early stages - from the years 1984 to 1994 - it developed and
marketed two ultrasound-based cardiac output devices: one that was integrated
into an endotrachial tube, and the other being a predecessor to the current
Basis Cardiac Output Monitoring System. Both products were sold or distributed
in the 1990's in small quantities. After a small commercialization effort, the
Company ceased marketing due to unreliable product performance caused by a
variety of factors, including inadequate probe sensitivity and signal
processing, and hardware performance constraints. Although management believes
that the Basis Cardiac Output Monitoring System incorporates design changes that
address the shortcomings of the prior systems, there can be no assurance that
performance problems will not occur in clinical use of the Basis Cardiac Output
Monitoring System.
NEED FOR ADDITIONAL FINANCING
The Company expects that additional financing will be needed in the first
quarter of 2000 to fund its development and product commercialization plans.
Such additional financing may include sales of debt or equity securities or
loans from banks or other financial institutions. Equity securities of the
Company could result in substantial additional dilution to shareholders.
Additionally, equity securities sold in the future could include shares of
previously undesignated preferred stock that could have rights and preferences
adversely affecting the rights of holders of Common Stock. If the Company's
operational plans do not progress as anticipated, the Company's ability to
attract additional financing could be impaired. No assurance can be given that
the Company will be able to obtain any additional financing on acceptable terms
or at all, and failure to do so would have a material, adverse effect on the
Company's business, financial condition and results of operations.
UNCERTAINTY OF MARKET ACCEPTANCE
The commercial success of the Company's Basis Cardiac Output Monitoring System
will require acceptance by cardiac surgeons and other medical specialists. Such
acceptance will depend, in part, upon clinical validation results and the
conclusion by these medical professionals that the Basis Cardiac Output
Monitoring System is accurate, reliable and effective and that that Basis
Cardiac Output Monitoring System
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EXHIBIT 99.1
offers enhanced functionality relative to current cardiac output monitoring
technologies. There can be no assurance that the Basis Cardiac Output Monitoring
System will provide clinical benefits considered superior by these professionals
or that a sufficient number of such professionals will use the Basis Cardiac
Output Monitoring System for commercial success to be achieved. Because the
Basis Cardiac Output Monitoring System represents a different method of clinical
assessment and an improved product compared to the Company's earlier development
efforts that failed to achieve commercial success, there may be greater
reluctance to accept this product than would occur with products using
well-established technologies. Substantial efforts may need to be devoted to
educating the market to the Company's technologically different approach and the
improvements in the Basis Cardiac Output Monitoring System over the Company's
prior cardiac output monitoring systems. Failure of the Company's product to
achieve market acceptance would have a material adverse effect on the Company's
business, financial condition and results of operations.
LACK OF MANUFACTURING EXPERIENCE
The Company's current plans call for it to manufacture the Basis Cardiac Output
Monitoring System internally. The Company has only limited manufacturing
experience and could encounter difficulties in scaling up production. These
problems may include estimating optimal product volume and mix requirements,
production yields, controlling and anticipating product costs, quality control
and assurance, component supply and contending with shortages of qualified
personnel. There can be no assurance that manufacturing difficulties will not
occur. Such difficulties could have a material adverse effect on the Company.
LACK OF MARKETING EXPERIENCE
A key element of the Company's business strategy is to market and sell the Basis
Cardiac Output Monitoring System through a direct sales organization in the
United States and through an international distribution network. The Company has
no experience in marketing the Basis Cardiac Output Monitoring System and no
current sales capabilities. There can be no assurance that the Company's
proposed marketing efforts will result in commercial sales or that the Company
will be able to develop an effective sales force and distribution network
without incurring substantial delays or costs or at all. Failure to develop an
effective direct sales organization or an effective international distribution
network would have a material adverse effect on the Company.
COMPETITION
Competition in the medical device industry in general and in the market for
cardiac output monitoring in particular is intense. The cardiac output
monitoring market is currently dominated by companies such as Edwards Critical
Care (a division of Baxter Healthcare Corporation), Johnson and Johnson and
Abbott Critical Care who make and sell catheters, thermodilution cardiac
monitors and peripheral products used to measure cardiac output by the widely
used thermodilution method. While the Company believes its Basis Cardiac Output
Monitoring System represents significant improvements over existing products in
the marketplace, the Company must be able to effectively demonstrate the
beneficial features of the Basis Cardiac Output Monitoring System and must
maintain competitive pricing in order to successfully sell its products.
Competition in the Company's market may result in pricing pressures that may
adversely affect product gross margins. The Company competes with the companies
listed above and other large companies, many of which have greater resources and
established operations. These competitors also have greater depth in research
and development, manufacturing and marketing and sales capabilities. The ability
of the Company to compete effectively will depend upon the advantages and
proprietary nature of the Basis Cardiac Output Monitoring System, on the
Company's ability to attain and maintain technological leadership and to
generate sales. There can be no assurance that the Company will be able to
successfully compete against its current or future competitors.
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EXHIBIT 99.1
LIMITED HUMAN USE OF THE BASIS CARDIAC OUTPUT MONITORING SYSTEM
To date, the Company has completed extensive research, conducted lab and animal
testing and conducted limited human clinical use of the Basis Cardiac Output
Monitoring System. Although the Company believes that its research and testing
provide conclusive support for the Basis Cardiac Output Monitoring System's
performance in humans, there can be no assurance that research and animal
testing alone will identify all the technical issues or potential problems with
use of the Basis Cardiac Output Monitoring System in humans in generally, or in
any subset of humans having differing anatomical structures or disease
characteristics. The Company began product evaluations of the Basis Cardiac
Output Monitoring System and RealFlow Probe at one clinical site in the U.S.
Early results from these evaluations indicate the need for modifications to the
Basis Cardiac Output Monitoring System in order to meet the Company's product
performance expectations. While the Company intends to make these modifications
before continuing with further product evaluations at its clinical sites, there
can be no assurance that the necessary modifications can be timely and
successfully developed. Any failure of the Basis Cardiac Output Monitoring
System to achieve acceptable results in future evaluations could lead to delays
in the introduction and market acceptance of the Basis Cardiac Output Monitoring
System. A delay in market introduction of the Basis Cardiac Output Monitoring
System would have a material adverse effect on the Company's business, financial
condition and results of operations.
TECHNOLOGICAL OBSOLESCENCE; DEVELOPMENT OF NEW PRODUCTS
Rapid technological advances characterize the medical device market. Even if the
Basis Cardiac Output Monitoring System is successfully developed and accepted,
it may be rendered obsolete by technological developments, new innovations or
changes in the medical marketplace. The Company's success will depend in part on
its ability to respond quickly to medical and technological changes and to
develop and introduce new, cost-effective versions of its Basis Cardiac Output
Monitoring System in response to competitive innovations. Development and
commercialization of new products will require additional research and
development expenditures and may require new regulatory approvals. There can be
no assurance that the Company will successfully identify new market
opportunities and develop new products or that these new products will receive
necessary regulatory approvals or be successfully received by the marketplace
or, if so, that the Company's products will not be rendered obsolete by changes
in technology.
LIMITATIONS ON THIRD PARTY REIMBURSEMENT
The Basis Cardiac Output Monitoring System will generally be purchased by
hospitals which then seek reimbursement from various public and private third
party payers covering cardiac surgery patients, such as Medicare, Medicaid and
private insurers, for the health care services provided to patients. There can
be no assurance that these third party payers will consider use of the Basis
Cardiac Output Monitoring System cost-effective. If the Basis Cardiac Output
Monitoring System is not considered cost-effective and not approved for
reimbursement, this will materially adversely affect the prospects of the Basis
Cardiac Output Monitoring System and the Company itself. Even if the third party
payers approve the Basis Cardiac Output Monitoring System for reimbursement,
there can be no assurance that the level of reimbursement approved will be high
enough to make the Company a profit from selling the Basis Cardiac Output
Monitoring System. Furthermore, the amount of reimbursement for treatment for
various cardiac diseases could decrease in the future and reduce the amount paid
for the Basis Cardiac Output Monitoring System. Failure by hospitals and other
users of the Company's products to obtain sufficient reimbursement for use of
the Basis Cardiac Output Monitoring System in cardiac output monitoring could
have a material adverse effect on the Company.
PATENTS AND PROPRIETARY RIGHTS
The Company's success depends in part on its ability to obtain and maintain
patent protection for its products, to preserve its trade secrets and to operate
without infringing the proprietary rights of third parties. The Company
currently holds five U.S. patents, two Canadian patents, one European patent
relating to devices and methods used to measure blood flow through a major
mammalian artery using ultrasound technology, as well as four U.S. patents
pending and patents and patent applications pending in Japan and European
countries relating to an endotrachial device. The validity and breadth of claims
covered in medical technology patents involve complex legal and factual
questions and, therefore, may be highly uncertain. No assurances can be given
that any current patents will be maintained, that patents under pending
applications or any future patent applications will be issued, that the scope of
any patent protection
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EXHIBIT 99.1
will exclude competitors or provide competitive advantages to the Company, that
any of the Company's patents will be held valid if subsequently challenged, that
others will not claim rights in or ownership of the patents and other
proprietary rights held by the Company or that the Basis Cardiac Output
Monitoring System or other products and processes will not infringe, or be
alleged to infringe, the proprietary rights of others.
If the Company is found to have infringed on the rights of a third party, the
Company may be unable to market its products without a license from such third
party. There is no assurance that the Company would be able to obtain such a
license on satisfactory terms, or at all. Furthermore, there can be no assurance
that others have not developed or will not develop similar products or
manufacturing processes, duplicate any of the Company's products or
manufacturing processes, or design around the Company's patents. In addition,
whether or not additional patents are issued to the Company, others may hold or
receive patents that contain claims having a scope that covers products
subsequently developed by the Company.
The Company also relies on unpatented trade secrets to protect its proprietary
technology, and no assurance can be given that others will not independently
develop or otherwise acquire substantially equivalent technologies or otherwise
gain access to the Company's proprietary technology or disclose such technology
or that the Company can ultimately protect meaningful rights to such unpatented
proprietary technology.
There has been substantial litigation regarding patent and other intellectual
property rights in the medical device industry. Litigation, which could result
in substantial cost to and diversion of effort by the Company, may be necessary
to enforce patents issued to the Company, to protect trade secrets or know-how
owned by the Company, to defend the Company against claimed infringement of the
rights of others or to determine the ownership, scope or validity of the
proprietary rights of the Company and others. An adverse determination in such
litigation could subject the Company to significant liabilities to third
parties, require the Company to seek licenses from third parties and prevent the
Company from manufacturing, selling or using its products, any of which could
have a material adverse effect on the Company's business, financial condition
and results of operations.
RISKS RELATED TO YEAR 2000 COMPLIANCE ISSUES
Many computer systems and applications use two-digit date fields to identify a
given year. The so-called "Year 2000" or "Y2K" problem is the failure of
date-sensitive computing systems and applications to properly recognize and
process dates into and after the Year 2000. These problems may cause incorrect
processing of financial and operational information, and could result in
business interruptions. Although the Company believes that the Basis Cardiac
Output Monitoring System is Y2K compliant and is currently seeking to identify
and remediate its Year 2000 risk with regard to its internal systems, there can
be no assurance that the Company will identify all of its potential Year 2000
issues. Additionally, while the Company plans to evaluate the Year 2000
compliance of its material vendors, distributors and other significant business
partners, there can be no assurance that these parties will successfully achieve
Year 2000 compliance for their products and internal systems. If the Company or
one of its significant business partners fails to identify and correct all Year
2000 problems, there could be a material adverse effect on the Company's
business, financial condition and results of operations.
GOVERNMENTAL REGULATION
As a medical device company, the Company is subject to extensive and rigorous
regulation by the FDA in the United States and by comparable agencies in foreign
countries. The FDA regulates the introduction of medical devices as well as
manufacturing, labeling, distribution, sale, marketing, advertising, promotion
and record keeping procedures for such products.
Although the 510(k) marketing clearance received from the FDA for the Company's
trans-aortic system was recently reviewed by the Company and outside advisors
and is believed to be valid for the Basis Cardiac Output Monitoring System, such
clearance can be withdrawn temporarily or permanently by the FDA due to failure
to comply with regulatory standards or the occurrence of unforeseen problems
with the Basis Cardiac Output Monitoring System. The FDA also has the power to
limit or prevent the manufacture
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EXHIBIT 99.1
or distribution of the Basis Cardiac Output Monitoring System and could require
its recall. FDA regulations depend heavily on administrative interpretation, and
there can be no assurance that future interpretation made by the FDA or other
regulatory bodies, with possible retroactive effect, will not adversely affect
the Company. The FDA and various agencies inspect the Company and its facilities
from time to time to determine whether the Company is in compliance with
regulations relating to medical device manufacturing, including regulations
concerning manufacturing, testing, quality control and product labeling
practices. A determination that the Company is in material violation of such
regulations could lead to the imposition of civil penalties, including fines,
product recalls, product seizures, or, in extreme cases, criminal sanctions. In
addition, there can be no assurance that the government regulations will not
change, and thereby prevent the Company from temporarily or permanently
marketing the Basis Cardiac Output Monitoring System. The withdrawal by the FDA
of its marketing approval for the Basis Cardiac Output Monitoring System, the
recall of the Basis Cardiac Output Monitoring System or similar regulatory
action would have a material adverse effect on the Company's business, financial
condition and results of operations.
As part of its strategy, the Company expects to pursue commercialization of its
products in international markets, and therefore, the Company's products will be
subject to regulations that vary from country to country. The process of
obtaining foreign regulatory approvals in certain countries can be lengthy and
require the expenditure of substantial resources. There can be no assurance that
the Company will be able to obtain necessary regulatory approvals or clearances
on a timely basis or at all, and delays in receipt of or failure to receive such
approvals or clearances, or failure to comply with existing or future regulatory
requirements, could have a material adverse effect on the Company's business,
financial condition and results of operations.
UNCERTAINTY OF HEALTH CARE REFORM
The levels of revenue and profitability of medical device companies may be
affected by the continuing efforts of government and third party payers to
contain or reduce the costs of health care through various means. In the United
States there have been, and the Company expects that there will continue to be,
a number of federal and state proposals to control health care costs. These
proposals contain measures intended to control public and private spending on
health care as well as to provide universal public access to the health care
system. If enacted, such proposals may result in a substantial restructuring of
the health care delivery system. Significant changes in the nation's health care
system are likely to have a substantial impact on the manner in which the
Company conducts its business and could have a material adverse effect on the
Company's business, financial condition and results of operations. Similarly,
the marketing and sale of the Company's products in foreign countries could be
materially adversely affected by health care reform in such countries.
NEED TO EXPAND; DEPENDENCE ON KEY PERSONNEL
The Company needs to expand its management, research and development,
manufacturing and sales and marketing personnel in order to support development
and commercialization of the Basis Cardiac Output Monitoring System. The
inability to hire personnel as needed may have a material adverse effect on the
Company. The success of the Company will depend in part upon its ability to
attract and retain capable technical staff as well as sales and marketing
personnel in the future. The Company is currently dependent on the services of
Andrew M. Weiss, the Company's President and Chief Executive Officer, and Steven
R. Wedan, the Company's Vice-President, Engineering. The loss of either of
Messrs. Weiss or Wedan could have a material adverse effect on the Company.
RISKS RELATED TO INTERNATIONAL SALES
The Company's plan to distribute the Basis Cardiac Output Monitoring System in
international markets involves certain risks, including the impact of any
tariffs, quotas and taxes which may be imposed by foreign governments on
international sales of the Basis Cardiac Output Monitoring System, the impact of
potential political and economic instability on demand for the Basis Cardiac
Output Monitoring System, restrictions on import or export of technology which
could prohibit or restrict international sales, and
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EXHIBIT 99.1
potentially limited intellectual property protection which could cause the
Company to refrain from selling in certain international markets. Currency
fluctuations could also cause the Basis Cardiac Output Monitoring System to
become less affordable or less price competitive in international markets. Any
of these factors would adversely impact the Company's ability to sell the Basis
Cardiac Output Monitoring System internationally, and could in turn have a
material, adverse impact on the Company's business, financial condition and
results of operations.
DEPENDENCE ON KEY SUPPLIERS
There are multiple sources for most of the components used in the Basis Cardiac
Output Monitoring System. Several components, however, are currently available
from only a limited number of vendors. The inability to obtain such components
on a timely basis from such vendors would have an adverse impact on the
Company's ability to fill orders from customers.
PRODUCT LIABILITY; AVAILABILITY OF INSURANCE
The medical device industry is subject to substantial litigation, and the
Company faces an inherent business risk of exposure to product liability claims
in the event that the use of the Basis Cardiac Output Monitoring System is
alleged to have resulted in adverse effects to a patient. Although the Company
intends to maintain product liability insurance, there can be no assurance that
the coverage limits of its insurance policies will be adequate, or that such
insurance will be available in the future on acceptable terms, if at all. A
product liability claim or other claim with respect to uninsured liabilities or
in excess of insured liabilities could have a material adverse effect on the
business, financial conditions and results of operations of the Company.
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